BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY DR, U1.6 DF1 US

    MDR report key: 4810859 · Received June 2, 2015

    Report

    Report Number
    2938836-2015-26670
    Event Type
    Death
    Date Received
    June 2, 2015
    Date of Event
    March 23, 2015
    Report Date
    April 6, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P030054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355514 FORTIFY DR, U1.6 DF1 US IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD2231-40 3785292

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death (B)(4)| (B)(4)